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The Cochrane Database of Systematic... Jun 2017Women with a prior caesarean delivery have an increased risk of uterine rupture and for women subsequently requiring induction of labour it is unclear which method is... (Review)
Review
BACKGROUND
Women with a prior caesarean delivery have an increased risk of uterine rupture and for women subsequently requiring induction of labour it is unclear which method is preferable to avoid adverse outcomes. This is an update of a review that was published in 2013.
OBJECTIVES
To assess the benefits and harms associated with different methods used to induce labour in women who have had a previous caesarean birth.
SEARCH METHODS
We searched Cochrane Pregnancy and Childbirth's Trials Register (31 August 2016) and reference lists of retrieved studies.
SELECTION CRITERIA
Randomised controlled trials (RCTs) comparing any method of third trimester cervical ripening or labour induction, with placebo/no treatment or other methods in women with prior caesarean section requiring labour induction in a subsequent pregnancy.
DATA COLLECTION AND ANALYSIS
Two review authors independently assessed studies for inclusion and trial quality, extracted data, and checked them for accuracy.
MAIN RESULTS
Eight studies (data from 707 women and babies) are included in this updated review. Meta-analysis was not possible because studies compared different methods of labour induction. All included studies had at least one design limitation (i.e. lack of blinding, sample attrition, other bias, or reporting bias). One study stopped prematurely due to safety concerns. Vaginal PGE2 versus intravenous oxytocin (one trial, 42 women): no clear differences for caesarean section (risk ratio (RR) 0.67, 95% confidence interval (CI) 0.22 to 2.03, evidence graded low), serious neonatal morbidity or perinatal death (RR 3.00, 95% CI 0.13 to 69.70, evidence graded low), serious maternal morbidity or death (RR 3.00, 95% CI 0.13 to 69.70, evidence graded low). Also no clear differences between groups for the reported secondary outcomes. The GRADE outcomes vaginal delivery not achieved within 24 hours, and uterine hyperstimulation with fetal heart rate changes were not reported. Vaginal misoprostol versus intravenous oxytocin (one trial, 38 women): this trial stopped early because one woman who received misoprostol had a uterine rupture (RR 3.67, 95% CI 0.16 to 84.66) and one had uterine dehiscence. No other outcomes (including GRADE outcomes) were reported. Foley catheter versus intravenous oxytocin (one trial, subgroup of 53 women): no clear difference between groups for vaginal delivery not achieved within 24 hours (RR 1.47, 95% CI 0.89 to 2.44, evidence graded low), uterine hyperstimulation with fetal heart rate changes (RR 3.11, 95% CI 0.13 to 73.09, evidence graded low), and caesarean section (RR 0.93, 95% CI 0.45 to 1.92, evidence graded low). There were also no clear differences between groups for the reported secondary outcomes. The following GRADE outcomes were not reported: serious neonatal morbidity or perinatal death, and serious maternal morbidity or death. Double-balloon catheter versus vaginal PGE2 (one trial, subgroup of 26 women): no clear difference in caesarean section (RR 0.97, 95% CI 0.41 to 2.32, evidence graded very low). Vaginal delivery not achieved within 24 hours, uterine hyperstimulation with fetal heart rate changes, serious neonatal morbidity or perinatal death, and serious maternal morbidity or death were not reported. Oral mifepristone versus Foley catheter (one trial, 107 women): no primary/GRADE outcomes were reported. Fewer women induced with mifepristone required oxytocin augmentation (RR 0.54, 95% CI 0.38 to 0.76). There were slightly fewer cases of uterine rupture among women who received mifepristone, however this was not a clear difference between groups (RR 0.29, 95% CI 0.08 to 1.02). No other secondary outcomes were reported. Vaginal isosorbide mononitrate (IMN) versus Foley catheter (one trial, 80 women): fewer women induced with IMN achieved a vaginal delivery within 24 hours (RR 2.62, 95% CI 1.32 to 5.21, evidence graded low). There was no difference between groups in the number of women who had a caesarean section (RR 1.00, 95% CI 0.39 to 2.59, evidence graded very low). More women induced with IMN required oxytocin augmentation (RR 1.65, 95% CI 1.17 to 2.32). There were no clear differences in the other reported secondary outcomes. The following GRADE outcomes were not reported: uterine hyperstimulation with fetal heart rate changes, serious neonatal morbidity or perinatal death, and serious maternal morbidity or death. 80 mL versus 30 mL Foley catheter (one trial, 154 women): no clear difference between groups for the primary outcomes: vaginal delivery not achieved within 24 hours (RR 1.05, 95% CI 0.91 to 1.20, evidence graded moderate) and caesarean section (RR 1.05, 95% CI 0.89 to 1.24, evidence graded moderate). However, more women induced using a 30 mL Foley catheter required oxytocin augmentation (RR 0.81, 95% CI 0.66 to 0.98). There were no clear differences between groups for other secondary outcomes reported. Several GRADE outcomes were not reported: uterine hyperstimulation with fetal heart rate changes, serious neonatal morbidity or perinatal death, and serious maternal morbidity or death. Vaginal PGE2 pessary versus vaginal PGE2 tablet (one trial, 200 women): no difference between groups for caesarean section (RR 1.09, 95% CI 0.74 to 1.60, evidence graded very low), or any of the reported secondary outcomes. Several GRADE outcomes were not reported: vaginal delivery not achieved within 24 hours, uterine hyperstimulation with fetal heart rate changes, serious neonatal morbidity or perinatal death, and serious maternal morbidity or death.
AUTHORS' CONCLUSIONS
RCT evidence on methods of induction of labour for women with a prior caesarean section is inadequate, and studies are underpowered to detect clinically relevant differences for many outcomes. Several studies reported few of our prespecified outcomes and reporting of infant outcomes was especially scarce. The GRADE level for quality of evidence was moderate to very low, due to imprecision and study design limitations.High-quality, adequately-powered RCTs would be the best approach to determine the optimal method for induction of labour in women with a prior caesarean birth. However, such trials are unlikely to be undertaken due to the very large numbers needed to investigate the risk of infrequent but serious adverse outcomes (e.g. uterine rupture). Observational studies (cohort studies), including different methods of cervical ripening, may be the best alternative. Studies could compare methods believed to provide effective induction of labour with low risk of serious harm, and report the outcomes listed in this review.
Topics: Dinoprostone; Early Termination of Clinical Trials; Female; Humans; Labor, Induced; Misoprostol; Oxytocics; Oxytocin; Pregnancy; Randomized Controlled Trials as Topic; Uterine Rupture; Vaginal Birth after Cesarean
PubMed: 28599068
DOI: 10.1002/14651858.CD009792.pub3 -
The Cochrane Database of Systematic... Dec 2016Sometimes it is necessary to bring on labour artificially because of safety concerns for the mother or baby. This review is one of a series of reviews of methods of... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Sometimes it is necessary to bring on labour artificially because of safety concerns for the mother or baby. This review is one of a series of reviews of methods of labour induction using a standardised protocol.
OBJECTIVES
To determine the effects of NO donors (isosorbide mononitrate (ISMN), isosorbide dinitrate (ISDN), nitroglycerin and sodium nitroprusside) for third trimester cervical ripening or induction of labour, in comparison with placebo or no treatment or other treatments from a predefined hierarchy.
SEARCH METHODS
We searched Cochrane Pregnancy and Childbirth's Trials Register (15 August 2016) and the reference lists of trial reports.
SELECTION CRITERIA
Clinical trials comparing NO donors for cervical ripening or labour induction with other methods listed above it on a predefined list of methods of labour induction. Interventions include NO donors (isosorbide mononitrate, isosorbide dinitrate, nitroglycerin and sodium nitroprusside) compared with other methods listed above it on a predefined list of methods of labour induction.
DATA COLLECTION AND ANALYSIS
This review is part of a series of reviews focusing on methods of induction of labour, based on a generic protocol. Three review authors independently assessed trials for inclusion, assessed risk of bias and extracted data. In this update, the quality of the evidence for the main comparison was assessed using the GRADE approach.
MAIN RESULTS
We included 23 trials (including a total of 4777 women). Included studies compared NO donors with placebo, vaginal prostaglandin E2 (PGE2), intracervical PGE2, vaginal misoprostol and intracervical Foley catheter. The majority of the included studies were assessed as being at low risk of bias. Nitric oxide versus placebo There was no evidence of a difference for any of the primary outcomes analysed: vaginal delivery not achieved in 24 hours (risk ratio (RR) 0.97, 95% confidence interval (CI) 0.83 to 1.15; one trial, 238 women; low-quality evidence), uterine hyperstimulation with fetal heart rate (FHR) changes (RR 0.09, 95% CI 0.01 to 1.62; two trials, 300 women; low-quality evidence), caesarean section (RR 0.99, 95% CI 0.88 to 1.11; nine trials, 2624 women; moderate-quality evidence) or serious neonatal morbidity/perinatal death (average RR 1.61, 95% CI 0.08 to 33.26; two trials, 1712 women; low-quality evidence). There were no instances of serious maternal morbidity or death (one study reported this outcome).There was a reduction in an unfavourable cervix at 12 to 24 hours in women treated with NO donors (average RR 0.78, 95% CI 0.67 to 0.90; four trials, 762 women), and this difference was observed in both subgroups of standard release and slow release formulation. Women who received NO donors were less likely to experience uterine hyperstimulation without FHR rate changes (RR 0.05, 95% CI 0.00 to 0.80; one trial, 200 women), and more likely to experience side effects, including nausea, headache and vomiting. Nitric oxide donors versus vaginal prostaglandins There was no evidence of any difference between groups for uterine hyperstimulation with FHR changes or caesarean section (RR 0.97, 95% CI 0.78 to 1.21; three trials, 571 women). Serious neonatal morbidity and serious maternal morbidity were not reported. There were fewer women in the NO donor group who did not achieve a vaginal delivery within 24 hours (RR 0.63, 95% CI 0.47 to 0.86; one trial, 400 primiparae women). Nitric oxide donors versus intracervical prostaglandins One study reported a reduction in the number of women who had not achieved a vaginal delivery within 24 hours with NO donors (RR 0.63, 95% CI 0.47 to 0.86; one trial, 400 women). This result should be interpreted with caution as the information was extracted from an abstract only and a full report of the study is awaited. No differences were observed between groups for uterine hyperstimulation with FHR changes (RR 0.33, 95% CI 0.01 to 7.74; one trial, 42 women) or serious neonatal morbidity/perinatal death (RR 0.33, 95% CI 0.01 to 7.74; one trial, 42 women). Fewer women in the NO donor group underwent a caesarean section in comparison to women who received intracervical prostaglandins (RR 0.63, 95% CI 0.44 to 0.90; two trials, 442 women). No study reported on the outcome serious maternal morbidity or death. Nitric oxide donors versus vaginal misoprostol There was a reduction in the rate of uterine hyperstimulation with FHR changes with NO donors (RR 0.07, 95% CI 0.01 to 0.37; three trials, 281 women). There were no differences in caesarean section rates (RR 1.00, 95% CI 0.82 to 1.21; 761 women; six trials) and no cases of serious neonatal morbidity/perinatal death were reported. One study found that women in the NO donor group were more likely to not deliver within 24 hours (RR 5.33, 95% CI 1.62 to 17.55; one trial, 150 women). Serious maternal morbidity or death was not reported.In terms of secondary outcomes, there was an increase in cervix unchanged/unfavourable with NO (RR 3.43, 95% CI 2.07 to 5.66; two trials, 151 women) and an increase in the need for oxytocin augmentation with NO induction (RR 2.67, 95% CI 1.31 to 5.45; 7 trials; 767 women), although there was evidence of significant heterogeneity which could not be fully explained. Uterine hyperstimulation without FHR was lower in the NO group, as was meconium-stained liquor, Apgar score less than seven at five minutes and analgesia requirements. Nitric oxide donors versus intracervical catheter There was no evidence on any difference between the effects of NO and the use of a Foley catheter for induction of labour for caesarean section (RR 1.00, 95% CI 0.39 to 2.59; one trial, 80 women). No other primary outcomes were reported. One study of 75 participants did not contribute any data to the review.For all comparisons, women who received NO donors were more likely to experience side effects such as headache, nausea or vomiting.
AUTHORS' CONCLUSIONS
Available data suggests that NO donors can be a useful tool in the process of induction of labour causing the cervix to be more favourable in comparison to placebo. However, additional data are needed to assess the true impact of NO donors on all important labour process and delivery outcomes.
Topics: Administration, Intravaginal; Cervical Ripening; Dinoprostone; Female; Humans; Labor, Induced; Misoprostol; Nitric Oxide Donors; Oxytocics; Pregnancy; Randomized Controlled Trials as Topic; Urinary Catheterization
PubMed: 27918616
DOI: 10.1002/14651858.CD006901.pub3 -
BJOG : An International Journal of... Nov 2016
Comparative Study Meta-Analysis Review
Re: A systematic review and network meta-analysis comparing the use of Foley catheters, misoprostol and dinoprostone for cervical ripening in induction of labour: Excessive, uterine activity is a maternal, neurological emergency.
Topics: Catheterization; Cervical Ripening; Dinoprostone; Female; Humans; Labor, Induced; Misoprostol; Oxytocics; Pregnancy; Pregnancy Outcome; Treatment Outcome; Urinary Catheters
PubMed: 27753252
DOI: 10.1111/1471-0528.14014 -
BJOG : An International Journal of... May 2017Induction of labour has become an increasingly common procedure. Ripening methods, including mechanical devices and pharmacological agents, improve the success rate of... (Comparative Study)
Comparative Study Meta-Analysis
BACKGROUND
Induction of labour has become an increasingly common procedure. Ripening methods, including mechanical devices and pharmacological agents, improve the success rate of labour induction.
OBJECTIVE
To compare the efficacy and safety of the double-balloon catheter with prostaglandin E2 agents used for labour induction.
SEARCH STRATEGY
We searched electronic sources from MEDLINE, Embase and Web of Science, the Cochrane Library Database of Systematic Reviews, and ClinicalTrials.gov website.
SELECTION CRITERIA
Only randomised controlled trials comparing the PGE2 agents with the double-balloon catheter for cervical ripening and labour induction in women with unfavourable cervices were included in the analysis.
DATA COLLECTION AND ANALYSIS
The main outcomes included the vaginal delivery rate within 24 hours and risk of caesarean section. We calculated relative risks and mean differences using fixed- and random-effects models.
MAIN RESULTS
Nine studies (1866 patients) were included in this systematic review. Both the double-balloon catheter and PGE2 agents were comparable with regard to rate of caesarean section (RR 0.92; 95% CI 0.79, 1.07), vaginal delivery within 24 hours (RR 0.95; 95% CI 0.78, 1.16) and maternal adverse events, but the risk of excessive uterine activity (RR 10.02; 95% CI 3.99, 25.17) and need for neonatal intensive care unit admissions (RR 1.31; 95% CI 1.01, 1.69) were significantly increased in women who received PGE2 agents.
CONCLUSIONS
The double-balloon catheter demonstrated greater safety and cost-effectiveness than PGE2 agents for cervical ripening and labour induction. The efficacy profiles of both methods were similar.
TWEETABLE ABSTRACT
Double-balloon catheter versus prostaglandin E2 for cervical ripening and labour induction.
Topics: Adult; Catheters; Cervical Ripening; Delivery, Obstetric; Dinoprostone; Female; Humans; Labor, Induced; Oxytocics; Pregnancy; Randomized Controlled Trials as Topic; Treatment Outcome
PubMed: 27533177
DOI: 10.1111/1471-0528.14256 -
American Journal of Obstetrics and... Aug 2016The aim of this systematic review and metaanalysis was to determine the efficacy and safety of cervical ripening agents in the second trimester of pregnancy in patients... (Meta-Analysis)
Meta-Analysis Review
OBJECTIVE
The aim of this systematic review and metaanalysis was to determine the efficacy and safety of cervical ripening agents in the second trimester of pregnancy in patients with previous cesarean delivery.
STUDY DESIGN
Data sources were PubMed, EMBASE, CINAHL, LILACS, Google Scholar, and clinicaltrials.gov (1983 through 2015). Eligibility criteria were cohort or cross-sectional studies that reported on efficacy and safety of cervical ripening agents in patients with previous cesarean delivery. Efficacy was determined based on the proportion of patients achieving vaginal delivery and vaginal delivery within 24 hours following administration of a cervical ripening agent. Safety was assessed by the risk of uterine rupture and complications such as retained placental products, blood transfusion requirement, and endometritis, when available, as secondary outcomes. Of the 176 studies identified, 38 met the inclusion criteria. Of these, 17 studies were descriptive and 21 studies compared the efficacy and safety of cervical ripening agents between patients with previous cesarean and those with no previous cesarean. From included studies, we abstracted data on cervical ripening agents and estimated the pooled risk differences and risk ratios with 95% confidence intervals. To account for between-study heterogeneity, we estimated risk ratios based on underlying random effects analyses. Publication bias was assessed via funnel plots and across-study heterogeneity was assessed based on the I(2) measure.
RESULTS
The most commonly used agent was PGE1. In descriptive studies, PGE1 was associated with a vaginal delivery rate of 96.8%, of which 76.3% occurred within 24 hours, uterine rupture in 0.8%, retained placenta in 10.8%, and endometritis in 3.9% in patients with ≥1 cesarean. In comparative studies, the use of PGE1, PGE2, and mechanical methods (laminaria and dilation and curettage) were equally efficacious in achieving vaginal delivery between patients with and without prior cesarean (risk ratio, 0.99, and 95% confidence interval, 0.98-1.00; risk ratio, 1.00, and 95% confidence interval, 0.98-1.02; and risk ratio, 1.00, and 95% confidence interval, 0.98-1.01; respectively). In patients with history of ≥1 cesarean the use of PGE1 was associated with higher risk of uterine rupture (risk ratio, 6.57; 95% confidence interval, 2.21-19.52) and retained placenta (risk ratio, 1.21; 95% confidence interval, 1.03-1.43) compared to women without a prior cesarean. However, the risk of uterine rupture among women with history of only 1 cesarean (0.47%) was not statistically significant (risk ratio, 2.36; 95% confidence interval, 0.39-14.32), whereas among those with history of ≥2 cesareans (2.5%) was increased as compared to those with no previous cesarean (0.08%) (risk ratio, 17.55; 95% confidence interval, 3.00-102.8). Funnel plots did not demonstrate any clear evidence of publication bias. Across-study heterogeneity ranged from 0-81%.
CONCLUSION
This systematic review and metaanalysis provides evidence that PGE1, PGE2, and mechanical methods are efficacious for achieving vaginal delivery in women with previous cesarean delivery. The use of prostaglandin PGE1 in the second trimester was not associated with significantly increased risk for uterine rupture among women with only 1 cesarean; however, this risk was substantially increased among women with ≥2 cesareans although the absolute risk appeared to be relatively small.
Topics: Administration, Intravaginal; Alprostadil; Cervical Ripening; Cesarean Section; Female; Humans; Labor, Induced; Pregnancy; Pregnancy Trimester, Second
PubMed: 27018469
DOI: 10.1016/j.ajog.2016.03.037 -
BJOG : An International Journal of... Aug 2016To compare the clinical effectiveness and cost-effectiveness of labour induction methods. (Meta-Analysis)
Meta-Analysis Review
OBJECTIVES
To compare the clinical effectiveness and cost-effectiveness of labour induction methods.
METHODS
We conducted a systematic review of randomised trials comparing interventions for third-trimester labour induction (search date: March 2014). Network meta-analysis was possible for six of nine prespecified key outcomes: vaginal delivery within 24 hours (VD24), caesarean section, uterine hyperstimulation, neonatal intensive care unit (NICU) admissions, instrumental delivery and infant Apgar scores. We developed a decision-tree model from a UK NHS perspective and calculated incremental cost-effectiveness ratios, expected costs, utilities and net benefit, and cost-effectiveness acceptability curves.
MAIN RESULTS
In all, 611 studies comparing 31 active interventions were included. Intravenous oxytocin with amniotomy and vaginal misoprostol (≥50 μg) were most likely to achieve VD24. Titrated low-dose oral misoprostol achieved the lowest odds of caesarean section, but there was considerable uncertainty in ranking estimates. Vaginal (≥50 μg) and buccal/sublingual misoprostol were most likely to increase uterine hyperstimulation with high uncertainty in ranking estimates. Compared with placebo, extra-amniotic prostaglandin E2 reduced NICU admissions. There were insufficient data to conduct analyses for maternal and neonatal mortality and serious morbidity or maternal satisfaction. Conclusions were robust after exclusion of studies at high risk of bias. Due to poor reporting of VD24, the cost-effectiveness analysis compared a subset of 20 interventions. There was considerable uncertainty in estimates, but buccal/sublingual and titrated (low-dose) misoprostol showed the highest probability of being most cost-effective.
CONCLUSIONS
Future trials should be designed and powered to detect a method that is more cost-effective than low-dose titrated oral misoprostol.
TWEETABLE ABSTRACT
New study ranks methods to induce labour in pregnant women on effectiveness and cost.
Topics: Administration, Intravaginal; Administration, Intravenous; Administration, Sublingual; Amniotomy; Apgar Score; Cesarean Section; Cost-Benefit Analysis; Delivery, Obstetric; Dinoprostone; Extraction, Obstetrical; Female; Humans; Intensive Care Units, Neonatal; Labor, Induced; Misoprostol; Network Meta-Analysis; Oxytocics; Oxytocin; Pregnancy
PubMed: 27001034
DOI: 10.1111/1471-0528.13981 -
PloS One 2016Marine-derived n-3 polyunsaturated fatty acids (PUFA) may have a beneficial effect on inflammation via lowering pro-inflammatory eicosanoid concentrations. We aimed to... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Marine-derived n-3 polyunsaturated fatty acids (PUFA) may have a beneficial effect on inflammation via lowering pro-inflammatory eicosanoid concentrations. We aimed to assess the effect of marine-derived n-3 PUFA on prostaglandin E2 (PGE2), thromboxane B2 (TXB2), and leukotriene B4 (LTB4) through systematic review and meta-analysis of randomized controlled trials.
METHOD AND FINDINGS
A structured search strategy on PubMed, Web of Science and Cochrane up to November 2015 was undertaken in this meta-analysis. Standard mean difference was used to calculate the effect size of marine-derived n-3 PUFA on PGE2, TXB2 and LTB4 in a random-effect model. A total of 18 RCTs with 826 subjects were included in this systematic review and meta-analysis. Supplementation of marine-derived n-3 PUFA significantly decreased concentrations of TXB2 in serum/plasma in subjects with high risk of cardiovascular diseases (SMD:-1.26; 95% CI: -1.65, -0.86) and LTB4 in neutrophils in unhealthy subjects (subjects with non-autoimmune chronic diseases or auto-immune diseases) (SMD:-0.59: 95% CI: -1.02, -0.16). Subgroup analyses showed a significant reduction of LTB4 in subjects with rheumatoid arthritis (SMD: -0.83; 95% CI: -1.37, -0.29), but not in non-autoimmune chronic disease patients (SMD: -0.33; 95% CI: -0.97, 0.31). No significant publication bias was shown in the meta-analysis.
CONCLUSIONS
Marine-derived n-3 PUFA had a beneficial effect on reducing the concentration of TXB2 in blood of subjects with high risk of CVD as well as LTB4 in neutrophils in unhealthy subjects, and that subjects with RA showed lower LTB4 content with supplementation of marine-derived n-3 PUFA.
Topics: Anti-Inflammatory Agents; Arthritis, Rheumatoid; Chronic Disease; Dietary Supplements; Dinoprostone; Dose-Response Relationship, Drug; Eicosanoids; Fatty Acids, Omega-3; Fish Oils; Humans; Leukotriene B4; Randomized Controlled Trials as Topic; Research Design; Thromboxane B2; Treatment Outcome
PubMed: 26808318
DOI: 10.1371/journal.pone.0147351 -
BJOG : An International Journal of... Feb 2016Various methods are used for cervical ripening during the induction of labour. It is still debatable which of these methods of treatment is optimal. (Comparative Study)
Comparative Study Meta-Analysis Review
BACKGROUND
Various methods are used for cervical ripening during the induction of labour. It is still debatable which of these methods of treatment is optimal.
OBJECTIVE
To compare treatment techniques for cervical ripening in the induction of labour.
SEARCH STRATEGY
Medline, Embase, and the Cochrane Collaboration databases were searched using the keywords 'cervical ripening', 'labour induced', 'misoprostol', 'dinoprostone', and 'Foley catheter'.
SELECTION CRITERIA
Randomised controlled trials (RCTs) of cervical ripening during the induction of labour, evaluating rates of failure to achieve vaginal delivery within 24 hours, incidence of uterine hyperstimulation with fetal heart rate (FHR) changes, and rates of caesarean section. Studies including women with prelabour rupture of membranes were excluded.
DATA COLLECTION AND ANALYSIS
Outcome data were collected and analysed through pairwise meta-analysis and network meta-analysis within a Bayesian framework.
MAIN RESULTS
A total of 96 RCTs (17,387 women) were included in the meta-analysis. Vaginal misoprostol was the most effective cervical ripening method to achieve vaginal delivery within 24 hours, but had the highest incidence of uterine hyperstimulation with FHR changes. The use of a Foley catheter to induce labour was associated with the lowest rate of uterine hyperstimulation accompanied by FHR changes. The caesarean section rate was lowest using oral misoprostol for the induction of labour.
AUTHOR'S CONCLUSIONS
No method of labour induction demonstrated overall superiority when considering all three clinical outcomes. Decisions regarding the choice of induction method will depend upon the relative preference for effecting vaginal delivery within 24 hours, minimising the incidence of uterine hyperstimulation with adverse FHR changes and avoiding caesarean section.
TWEETABLE ABSTRACT
Oral misoprostol for the induction of labour is safer than vaginal misoprostol and has the lowest rate of caesarean section.
Topics: Cervical Ripening; Dinoprostone; Female; Humans; Labor, Induced; Misoprostol; Oxytocics; Pregnancy; Randomized Controlled Trials as Topic; Urinary Catheterization; Urinary Catheters
PubMed: 26538408
DOI: 10.1111/1471-0528.13456 -
The Cochrane Database of Systematic... Apr 2015Hysteroscopy is an operation in which the gynaecologist examines the uterine cavity using a small telescopic instrument (hysteroscope) inserted via the vagina and the... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Hysteroscopy is an operation in which the gynaecologist examines the uterine cavity using a small telescopic instrument (hysteroscope) inserted via the vagina and the cervix. Almost 50% of hysteroscopic complications are related to difficulty with cervical entry. Potential complications include cervical tears, creation of a false passage, perforation, bleeding, or simply difficulty in entering the internal os (between the cervix and the uterus) with the hysteroscope. These complications may possibly be reduced with adequate preparation of the cervix (cervical ripening) prior to hysteroscopy. Cervical ripening agents include oral or vaginal prostaglandin, which can be synthetic (e.g misoprostol) or natural (e.g. dinoprostone) and vaginal osmotic dilators, which can be naturally occurring (e.g. laminaria) or synthetic.
OBJECTIVES
To determine whether preoperative cervical preparation facilitates cervical dilatation and reduces the complications of operative hysteroscopy in women undergoing the procedure for any condition.
SEARCH METHODS
In August 2014 we searched sources including the Menstrual Disorders and Subfertility Group (MDSG) Trials Register, Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, PsycINFO, CINAHL, ClinicalTrials.gov and reference lists of relevant articles. We searched for published and unpublished studies in any language.
SELECTION CRITERIA
Two review authors independently selected randomised controlled trials (RCTs) of cervical ripening agents used before operative hysteroscopy in pre- and postmenopausal women. Cervical ripening agents could be compared to each other, placebo or no treatment.
DATA COLLECTION AND ANALYSIS
Data extraction and quality assessment were conducted independently by two review authors. The primary review outcomes were effectiveness of cervical dilatation (defined as the proportion of women requiring mechanical cervical dilatation) and intraoperative complications. Secondary outcomes were mean time required to dilate the cervix, preoperative pain, cervical width, abandonment of the procedure, side effects of dilating agents and duration of surgery. We calculated odds ratios (ORs) for dichotomous outcomes and mean differences (MDs) for continuous outcomes, with 95% confidence intervals ( CIs). Data were statistically pooled where appropriate. Heterogeneity was assessed using the I(2) statistic. The overall quality of the evidence was assessed using GRADE methods.
MAIN RESULTS
Nineteen RCTs with a total of 1870 participants were included. They compared misoprostol with no treatment or placebo, dinoprostone or osmotic dilators.Misoprostol was more effective for cervical dilatation than placebo or no intervention, with fewer women requiring mechanical dilatation (OR 0.08, 95% CI 0.04 to 0.16, five RCTs, 441 participants, I(2)=0%, moderate quality evidence). This suggests that in a population in which 80% of women undergoing hysteroscopy require mechanical dilatation without use of preoperative ripening agents, use of misoprostol will reduce the need for mechanical dilatation to between 14% and 39%. Misoprostol was associated with fewer intraoperative complications (OR 0.37, 95% CI 0.18 to 0.77, 12 RCTs, 901 participants, I(2)=0%, moderate quality evidence). This suggests that in a population in which 3% of women undergoing hysteroscopy experience intraoperative complications without use of preoperative ripening agents, use of misoprostol will reduce the risk of complications to 2% or less.When specific complications were considered, the misoprostol group had a lower rate of cervical laceration or tearing (OR 0.25, 95% CI 0.11 to 0.57, nine RCTS, 669 women, I(2)=0%, moderate quality evidence) or false track formation (OR 0.34, 95% CI 0.12 to 0.97, seven RCTs, 560 participants, I(2)=0%, moderate quality evidence). There was no evidence of a difference between the groups in rates of uterine perforation (0.42, 95% CI 0.13 to 1.38, seven RCTs, 455 participants, I(2)=0%, low quality evidence) or uterine bleeding (OR 0.51, 95% CI 0.10 to 2.49, four RCTs, 340 participants, I(2)=0%, low quality evidence). Some treatment side effects (mild abdominal pain, vaginal bleeding, and increased body temperature) were more common in the misoprostol group.Compared with dinoprostone, misoprostol was associated with more effective cervical dilatation, with fewer women requiring mechanical dilatation (OR 0.58; 95% CI 0.34 to 0.98; one RCT, 310 participants, low quality evidence) and with fewer intraoperative complications (OR 0.32; 95% CI 0.12 to 0.83, one RCT, 310 participants, low quality evidence). However treatment side effects were more common in the misoprostol arm.Compared to osmotic dilatation (laminaria), misoprostol was associated with less effective cervical dilatation, with more women in the misoprostol group requiring mechanical dilatation (OR 5.96, 95% CI 2.61 to 13.59, one RCT, 110 participants, low quality evidence). There was no evidence of a difference between misoprostol and osmotic dilators in intraoperative complication rates (OR 5.14, 95% CI 0.24 to 109.01, three RCTs, 354 participants, low quality evidence), with only two events reported altogether.The overall quality of the evidence ranged from low to moderate. The main limitations in the evidence were imprecision and poor reporting of study methods.
AUTHORS' CONCLUSIONS
There is moderate quality evidence that use of misoprostol for preoperative ripening of the cervix before operative hysteroscopy is more effective than placebo or no treatment and is associated with fewer intraoperative complications such as lacerations and false tracks. However misoprostol is associated with more side effects, including preoperative pain and vaginal bleeding. There is low quality evidence to suggest that misoprostol has fewer intraoperative complications and is more effective than dinoprostone.There is also low quality evidence to suggest that laminaria may be more effective than misoprostol, with uncertain effects for complication rates. However the possible benefits of laminaria need to be weighed against the inconvenience of its insertion and retention for one to two days.
Topics: Cervical Ripening; Cervix Uteri; Dilatation; Dinoprostone; Female; Humans; Hysteroscopy; Laminaria; Misoprostol; Oxytocics; Pregnancy; Preoperative Care; Randomized Controlled Trials as Topic
PubMed: 25906113
DOI: 10.1002/14651858.CD005998.pub2 -
Journal de Gynecologie, Obstetrique Et... Dec 2014This chapter is an update of the 2004 recommendations for the management of persistent or severe postpartum hemorrhage (PPH) after natural childbirth. Severe PPH is... (Review)
Review
INTRODUCTION
This chapter is an update of the 2004 recommendations for the management of persistent or severe postpartum hemorrhage (PPH) after natural childbirth. Severe PPH is defined by estimated blood loss greater than 1000mL (gradeC). Persistent bleeding within 15 to 30minutes after diagnosis and initial treatment (gradeC) or abundant immediately (professional consensus) should lead to a further management.
MATERIALS AND METHODS
A systematic review of the literature concerning the management of persistent or severe PPH was conducted on Medline and Cochrane Database, with no specified time period.
RESULTS AND DISCUSSION
The initial clinical evaluation is the same whatever initial severity. Each possible cause of bleeding must be evaluated: uterine vacuity must be checked and birth canal lesions must be researched and repaired (gradeC). Sulprostone is effective for the treatment of severe or persistent PPH (EL4) and its use is recommended for the management of PPH resistant to oxytocin administration (grade B). In the current state of the literature, there is no argument for replacing sulprostone in France by dinoprostone or prostaglandins F2α (professional consensus). If oxytocin has been administered, it is not recommended to use misoprostol (EL1) as adjuvant treatment because there is no evidence of benefit in this indication (grade A). Balloon intra-uterine tamponade appears to be an efficient mechanical treatment of uterine atony in case of failure of the initial management by sulprostone. Tamponade allows avoiding the need for further interventional radiology or surgery in most cases (EL4). Intra-uterine tamponade may be offered in case of failure of sulprostone and prior to surgical management or interventional radiology (professional consensus). Its use is left to the discretion of the practitioner. Tamponade should not delay the implementation of further invasive procedures.
Topics: Female; Humans; Postpartum Hemorrhage; Practice Guidelines as Topic; Uterine Balloon Tamponade
PubMed: 25447391
DOI: 10.1016/j.jgyn.2014.09.028